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Spinal Cord Stimulation for the Treatment of Major Depressive Disorder (SPIDEP)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Active transcutaneous spinal direct current stimulation
Sham transcutaneous spinal direct current stimulation
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, transcutaneous spinal direct current stimulation, non-invasive, major depressive disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. age 18-55 yrs., inclusive
  2. female or male
  3. BMI 18.5 to 35 kg/mts2, inclusive
  4. current MDD episode diagnoses confirmed by Mini International Neuropsychiatric Interview (MINI) 5.0 with a duration of ≥1 month and ≤24 months
  5. moderate MDD symptoms according to Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20 to ≤35
  6. no current or recent (past month) antidepressant pharmacological treatment
  7. GAD and other anxiety symptoms will be permitted
  8. using an effective contraceptive method (all participants of childbearing potential).

Exclusion criteria:

  1. Current or lifetime MDD episode non-responsive to two or more antidepressant treatments at adequate doses and time (including ECT)
  2. Current or lifetime bipolar disorder or schizophrenia diagnosis
  3. current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed)
  4. significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year
  5. current chronic severe pain conditions
  6. current chronic use of: opioids analgesics, medications that affect blood pressure or drugs with significant autonomic effects (stimulants and antipsychotics allowed if dose stable for 1 month)
  7. neurological, endocrinological, cardiovascular (including diagnosed hypertension) or other clinically significant medical conditions as judged by the clinician
  8. skin lesions on electrode placement region
  9. implanted electrical medical devices
  10. Pregnancy
  11. suspected IQ<80
  12. any other clinically relevant reason as judged by the clinician.

Sites / Locations

  • Lindner Center of HOPE/University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Treatment

Sham Treatment

Arm Description

Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks.

Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks.

Outcomes

Primary Outcome Measures

MADRS score change
Difference in change from baseline to week 8 (or last available observation) in MADRS scores between active and sham tsDCS groups.

Secondary Outcome Measures

Adverse Event frequency difference
Differences in adverse event frequency between active and sham tsDCS groups
Clinical Global Impression-Severity (CGI-S)
CGI-S change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Clinical Global Impression-Improvement (CGI-I)
CGI-I change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
MADRS Sub-component score
MADRS Sub-Component score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
PHQ-9 score change
PHQ-9 score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Multidimensional Assessment of Interoceptive Awareness (MAIA) score change
MAIA score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Binge Eating Scale (BES) score change
BES score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Four-Dimensional Symptom Questionnaire (4-DSQ) score change
4-DSQ score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Blood Pressure score change
Blood Pressure score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Heart Rate score change
Heart Rate score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Body Mass Index change
BMI change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Waist Circumference change
Waist Circumference score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Hip Circumference change
Hip Circumference score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Adiponectin level change
Adiponectin level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Leptin level change
Leptin level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Cortisol level change
Cortisol level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Insulin level change
Insulinl level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
FGF-21 level change
FGF-21 level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Fatty Acid (LCn-3) level change
Fatty Acid (LCn-3) level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.

Full Information

First Posted
February 8, 2018
Last Updated
October 10, 2022
Sponsor
University of Cincinnati
Collaborators
Lindner Center of HOPE, Brain & Behavior Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03433339
Brief Title
Spinal Cord Stimulation for the Treatment of Major Depressive Disorder
Acronym
SPIDEP
Official Title
Spinal Cord Stimulation for the Treatment of Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 29, 2018 (Actual)
Primary Completion Date
September 13, 2022 (Actual)
Study Completion Date
September 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Lindner Center of HOPE, Brain & Behavior Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot clinical trial will evaluate the efficacy and safety of transcutaneous direct current stimulation (tsDCS) in major depressive disorder.
Detailed Description
This study aims to 1) determine the efficacy and safety of tsDCS in adult patients with MDD and 2) investigate interoceptive awareness, somatic symptoms, autonomic and metabolic regulation as potential mediators of antidepressant response to tsDCS. We predict that 1) Active tsDCS treatment will result in a greater decrease in depressive symptom severity compared to Sham tsDCS in adult patients with MDD, 2) active tsDCS will be safe and well tolerated in adult patients with MDD and 3) change in interoceptive awareness, somatic symptoms, and autonomic and metabolic parameters will be associated with change in depressive symptom severity. To accomplish these aims, we will conduct an 8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design. A total of 20 adult antidepressant-free MDD patients will be randomized to receive Active (n=10) or Sham (n=10) tsDCS protocols for 8 weeks in a 1:1 ratio. We will combine the use of a tsDCS device, psychometric instruments to diagnose MDD, and measures of depressive symptom severity, somatic symptoms, interoceptive awareness, autonomic function (blood pressure, heart rate), and potential metabolic markers as predictors of response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, transcutaneous spinal direct current stimulation, non-invasive, major depressive disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
An independent operator (trained personnel from the research team) will prepare the tsDCS device parameters for each session, but will not participate in the rest of the assessments. Patients and raters will remain blinded to spinal stimulaion protocol assigned to each participant throughout the study.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
Thoracic anodal transcutaneous spinal direct current stimulation 2.5mA for 20 min/ three times per week for 8 weeks.
Arm Title
Sham Treatment
Arm Type
Sham Comparator
Arm Description
Thoracic anodal transcutaneous spinal direct current sham stimulation session of 20min/ three times per week for 8 weeks.
Intervention Type
Device
Intervention Name(s)
Active transcutaneous spinal direct current stimulation
Intervention Description
Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Intervention Type
Device
Intervention Name(s)
Sham transcutaneous spinal direct current stimulation
Intervention Description
Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Primary Outcome Measure Information:
Title
MADRS score change
Description
Difference in change from baseline to week 8 (or last available observation) in MADRS scores between active and sham tsDCS groups.
Time Frame
8 weeks (or last available observation).
Secondary Outcome Measure Information:
Title
Adverse Event frequency difference
Description
Differences in adverse event frequency between active and sham tsDCS groups
Time Frame
8 weeks
Title
Clinical Global Impression-Severity (CGI-S)
Description
CGI-S change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Clinical Global Impression-Improvement (CGI-I)
Description
CGI-I change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
MADRS Sub-component score
Description
MADRS Sub-Component score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
PHQ-9 score change
Description
PHQ-9 score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Multidimensional Assessment of Interoceptive Awareness (MAIA) score change
Description
MAIA score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Binge Eating Scale (BES) score change
Description
BES score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Four-Dimensional Symptom Questionnaire (4-DSQ) score change
Description
4-DSQ score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Blood Pressure score change
Description
Blood Pressure score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Heart Rate score change
Description
Heart Rate score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Body Mass Index change
Description
BMI change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Waist Circumference change
Description
Waist Circumference score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Hip Circumference change
Description
Hip Circumference score change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Adiponectin level change
Description
Adiponectin level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Leptin level change
Description
Leptin level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Cortisol level change
Description
Cortisol level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Insulin level change
Description
Insulinl level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
FGF-21 level change
Description
FGF-21 level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Title
Fatty Acid (LCn-3) level change
Description
Fatty Acid (LCn-3) level change from baseline to week 8 (or last available observation) difference between Active and Sham tsDCS groups.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Emotion recognition task scores change (exploratory)
Description
Emotion recognition task scores change from baseline to week 8 (or last available observation)
Time Frame
8 weeks
Title
Stop signal task scores change (exploratory)
Description
Stop signal task scores change from baseline to week 8 (or last available observation)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: age 18-55 yrs., inclusive female or male BMI 18.5 to 35 kg/mts2, inclusive current MDD episode diagnoses confirmed by Mini International Neuropsychiatric Interview (MINI) 5.0 with a duration of ≥1 month and ≤24 months moderate MDD symptoms according to Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20 to ≤35 no current or recent (past month) antidepressant pharmacological treatment GAD and other anxiety symptoms will be permitted using an effective contraceptive method (all participants of childbearing potential). Exclusion criteria: Current or lifetime MDD episode non-responsive to two or more antidepressant treatments at adequate doses and time (including ECT) Current or lifetime bipolar disorder or schizophrenia diagnosis current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed) significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year current chronic severe pain conditions current chronic use of: opioids analgesics, medications that affect blood pressure or drugs with significant autonomic effects (stimulants and antipsychotics allowed if dose stable for 1 month) neurological, endocrinological, cardiovascular (including diagnosed hypertension) or other clinically significant medical conditions as judged by the clinician skin lesions on electrode placement region implanted electrical medical devices Pregnancy suspected IQ<80 any other clinically relevant reason as judged by the clinician.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Romo-Nava, MD,PhD
Organizational Affiliation
University of Cincinnati/ Lindner Center of HOPE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lindner Center of HOPE/University of Cincinnati
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
A plan for individual participant data is not included in the current protocol. Following Federal, State and Institutional regulations, data could be shared with other researchers after the study ends.

Learn more about this trial

Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

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